C&Q COP Articles

Pharmaceutical Engineering Articles

Articles published in Pharmaceutical Engineering, ISPE’s bi-monthly member magazine that relate to the subject matter of the C&Q COP.

• Commissioning, Qualification, and Verification – Lean Approach to Implementation ( 2 MB)
  November/December 2009, 29(6)
  By Ms. Sabra Seyer, Dr. Graham Wrigley, Mr. Gert Moelgaard, Mr. Nicholas Andreopoulos
• Applying Quality Risk Management Principles to Achieve a Practical Verification Strategy ( 5 MB)
  November/December 2009, 29(6)
  By Mr. Ian Campbell
• Good Weighing Practices for the Pharmaceutical Industry – Risk-Based Qualification and Life Cycle Management of Weighing Systems ( 8 MB)
  November-December 2009, 29(6)
  By Dr. Klaus Fritsch
• Integration of Commissioning and Qualification (C&Q) with Other Phases of the Project Lifecycle ( 370 KB)
  May/June 2007, 27(3)
  By John Devlin
• Risk-Based Equipment Qualification: A User/Supplier Cooperative Approach ( 599 KB)
  July/August 2007, 27(4)
  By Sandro De Caris, Marco Bellentani, Beny Fricano, Carlo Bestetti, Marco Silvestri, Barbara Testoni
• Commissioning and Qualification: A New ASTM Standard – GMP Regulations ( 262 KB)
  November/December 2007, 27(6)
  By Robert E. Chew, David Petko
• The Power of Planning and how it Translates to Commissioning Efforts ( 265 KB)
  March/April 2006, 26(2)
  By Katie Henchir
• Design Qualification in Practice – from Strategy to Report ( 172 KB)
  July/August 200), 25(4)
  By Yossi Chvaicer
• A Practical Approach to Commissioning and Qualification - A Symbiotic Relationship ( 310 KB)
  Pharmaceutical Engineering (July/August 2004), 24(4).
  By Timothy D Blackburn
• Validation Outsourcing Best Practices: What Does this Mean for the Client-Contractor Relationship? ( 464 KB)
  July/August 2004, 24(4)
  By Katie Henchir, Cynthia Ingols
• Commissioning and Time-To-Market ( 501 KB)
  July/August 2004, 24(4)
  By Wael Allan
• Regulatory Requirements for Computer Infrastructures ( 312 KB)
  May/June, 2003, 23(3)
  By Orlando Lopez

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